Be part of the leading edge of cancer treatment and join our Cross Cancer Institute Clinical Trials Unit. The Project Manager, Cellular Therapies is a professional position supporting pharmaceutical sponsored cellular therapies overlapping across hematology and oncology within Edmonton. The role reports to the Clinical Trial Manager within the Cross Cancer Institute. This role will focus on the management and coordination of complex cellular therapy protocols while standardizing and centralizing Unit and site practices to facilitate process improvements. The Project Manager will work with CCA clinical leaders, Clinical Trial Unit (CTU) members, Pharmaceutical sponsors, Clinical Research Organizations (CRO) and Alberta Health Services researchers to ensure the successful design, initiation, planning, implementation, and evaluation of cellular sponsor driven clinical trials.
Applying project management, change management, risk management and quality and process improvement methodology towards project execution. Coordinate complex new cellular pharmaceutical protocols; protocol review, consideration of practical CAR T-cell manufacturing, regulatory and patient safety concerns, clinical use planning. Interpreting, understanding and applying Good Clinical Practice (GCP), Clinical Trial Unit Standard Operating Procedures (SOP) and regulatory requirements to the conduct of sponsor trials. Identifying opportunities for innovation and quality improvement within current practice. Presenting, facilitating and leading assigned process improvement projects; working with department management and oncologists/physicians to assure appropriate participation and support. Completing Operational approvals for all sponsor cellular therapy trials; working with other CCI departments, & outside hospitals and services to solve issues and resolve questions. Collaboration with the CTU Investigator Initiated Trial (IIT) Team for future CTU managed cellular therapy Investigator Initiated Trials. Regular interactions with clinical providers (MD’s, RN’s) for direction regarding clinical implementation of cellular therapy as well as determining any necessary changes/revisions to SOPs. Coordinate and attend meetings, and relevant medical rounds. Manage relationships across CCI, the University Hospital and other facilities as necessary for each specific trial. Provides support and guidance to clinical trial coordinators and nurses. Liaising with other involved parties (e.g. pharmaceutical partners) to develop cost-effectiveness models; inform health administrators regarding health service usage statistics and safety. Relationship and conflict management, and excellent communication are important components of the position.
Classification: Project Manager
Department: CCI CTU Indirect Cost
Primary Location: Cross Cancer Institute
Negotiable Location: Within Edmonton Zone
Temporary Employee Class: Temp F/T Benefits
Posting End Date: 15-JUL-2020
Date Available: 24-AUG-2020
Temporary End Date: 25-AUG-2021
Hours per Shift: 7.75
Length of Shift in weeks: 2
Shifts per cycle: 10
Shift Pattern: Days
Days Off: Saturday/Sunday
Minimum Salary: $28.20
Maximum Salary: $48.45
Vehicle Requirement: N/A
Baccalaureate Degree in a health related field required. Minimum 3 years’ experience leading projects using project management and/or quality and process improvement methodologies and tools. 5 years’ experience in an oncology health care setting. Formal project management training. Minimum 1 year experience in a leadership role. Knowledge and experience with CAR T-cells or immunotherapy. Strong problem solving skills and the ability to manage multiple projects simultaneously. Effective communicator with strong organizational skills, influential skills, client focused orientation and commitment to providing quality services. Demonstrated ability and comfort with decision making responsibilities, coaching and teaching, and the ability to motivate, inspire and build confidence in others to achieve common goals. Ability to work both independently and within a team structure. Knowledge of clinical systems, as well as the literature, resources and research related to cellular therapy are essential for this role.
Additional Required Qualifications:
Strong knowledge of and commitment to the principles and practice of Patient & Family Centered Care and Engagement. A demonstrated clear pattern of professional and personal development. Demonstrated knowledge and expertise in areas of project management, change management, data analysis and evaluation, quality and process improvement, risk management. Knowledge of clinical systems, as well as the literature, resources and research related to cellular therapy are essential for this role.
Project management designation (i.e. PMP) is an asset. Master’s Degree in a Health related field preferred.